Regulatory Startup Support Services

The CCTS Regulatory Knowledge and Support core can help investigators navigate the study start-up process by providing the following services:

  • 2 hour complimentary consultation

  • Assistance with IRB and/or FDA Submissions

  • Assistance with Protocol Development

  • Creation of Regulatory Binder

  • Assistance with Regulatory documents (i.e. 1572, Financial Disclosure, Site Signature, Delegation log, CV, Medical License, Laboratory certification, etc.)

  • Serve as a liaison with study sponsor